Reported Feb 24, 2016 · Terminated
GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope…
Verathon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Verathon, Inc. · 20001 N Creek Pkwy · Bothell, WA · 98011-8218
Is this the product you have?
- GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5)
- GVLThe GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor
- AVLThe GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Affected GVL Reusable Blades Serial Numbers, by Part Number GVL 3- 0574-0007: MD131859- MD151622 2 GVL 4- 0574-0001: LG131994- LG151773 3 GVL 5- 0574-0030: XL131577- XL151524. Affected AVL Reusable Blades Serial Numbers, by Part Numbers: AVL 2- 0574-0118: AC131852- AC151510 4 AVL 3- 0574-0115: AD131589- AD151506 5 AVL 4- 0574-0116: AE131586- AE151558 6 AVL 5- 0574-0117: AF131503- AF151500. - Amount recalled
- total 9088 units ( 5786 units in the US and 3302 units International)
Why it was recalled
Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.
This product could cause temporary or reversible health problems — stop using it.
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